Lens, Multifocal Intraocular
Basic Information
- Device Name
- Lens, Multifocal Intraocular
- Trade Name
- enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL)
- PMA Number
- P240005
- Device Class
- FDA Class 3
- Product Code
- MFK
- Generic Name
- Lens, multifocal intraocular
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 10, 2024
- Date Received
- March 8, 2024
- Expedited Review
- N
Advisory Committee Statement
Approval for the enVista Envy hydrophobic acrylic intraocular lens (IOL) and the enVista Envy toric hydrophobic acrylic IOL. The enVista Envy hydrophobic acrylic IOL (non-preloaded model: EN / preloaded into shuttle model: EPN) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia with less than or equal to 1.0 D preoperative corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL. The enVista Envy Toric hydrophobic acrylic IOL (non-preloaded model: ETN / preloaded into shuttle model: ETPN) is indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia and corneal astigmatism following removal of a cataractous lens to mitigate the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity to an aspheric monofocal IOL.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MFK | Lens, Multifocal Intraocular | FDA class 3 | Ophthalmic |